1. Field of the Invention
The present invention in general relates to a device and to a method for pre-operatively demonstrating at least partially implantable hearing systems for the rehabilitation of hearing disorders. More particularly, the present invention relates to a device for pre-operatively demonstrating an at least partially implantable hearing system for the rehabilitation of hearing disorders, which device includes an electromechanical transducer adapted for being non-invasively coupled from the side of the external auditory canal to at least approximately the center of the tympanic membrane and thus to the end point of the manubrium mallei for producing mechanical vibrations of the tympanic membrane, and an electronic audio signal generator unit. The present invention further is concerned with a method for pre-operatively demonstrating an at least partially implantable hearing system, which system includes an audio signal processing unit and an electromechanical transducer which is driven by the audio signal processing unit and is adapted for being coupled to a preselected coupling site, particularly to the ossicular chain, for causing mechanical vibrations of the coupling site.
2. Description of Related Art
In addition to rehabilitation of congenitally deaf persons and those who have lost their hearing using cochlear implants, for some time, there have been approaches to offer better rehabilitation than with conventional hearing aids to patients with a sensorineural hearing disorder which cannot be surgically corrected, by using partially or totally implantable hearing aids. In most embodiments the principle consists in stimulating, via a mechanical or hydromechanical stimulus, an ossicle of the middle ear or directly the inner ear, rather than via an amplified acoustic signal of a conventional hearing aid in which the amplified acoustic signal is supplied to the external auditory canal. The actuator stimulus of these electromechanical systems is accomplished by different physical transducer principles, such as, for example, by electromagnetic and piezoelectric systems. The advantage of these processes is seen mainly in the sound quality which is improved as compared to conventional hearing aids, and, in the case of totally implanted systems, in the fact that the hearing prosthesis is not visible. Such partially and fully implantable electromechanical hearing aids are described, for example, by Yanigahara et al. (Arch Otolaryngol Head Neck, Surg, Vol. 113, August 1987, pp. 869872); Hoke, M. (ed), (Advances in Audiology, Vol. 4, Karger Basel, 1988); H. P. Zenner et al. (HNO 1998, Vol. 46, pp. 844-852; H. Leysieffer et al. (xe2x80x9cA totally implantable hearing device for the treatment of sensorineural hearing loss: TICA LZ 3001xe2x80x9d, in HNO Vol. 46, 1998, pp. 853-863); and H. P. Zenner et al. (xe2x80x9cTotally implantable hearing device for sensorineural hearing lossxe2x80x9d, The Lancet, Vol. 352, November 1998, No. 9142, page 1751), as well as in numerous patent documents, among others in U.S. Pat. Nos. 5,360,388; 5,772,575; 5,814,095 and 5,984,859.
Recently, such partially and fully implantable electromechanical hearing aids for the rehabilitation of internal ear damages have been introduced into clinical use. In this connection it turned out to be desirable to demonstrate to the patient to be provided with the implant the improvement of hearing or the sound quality, respectively, to be expected. The known audiological methods which until now merely provide for a stimulation of the hearing by sound transmission through the air or through the human body, do not permit such a demonstration without surgical intervention.
There are approaches for testing the middle ear by direct contact with an electromechanical transducer. In conformity with Zoellner (A. Thullen, xe2x80x9cClinical experiences with the sound probe according to Zoellnerxe2x80x9d, Medizinal-Markt, Vol. 4, No. 12, December 1956, pages 444 and 445) a sound probe is contacted with the middle ear, particularly invasively during middle ear operations. A device for electromechanical testing of hearing (U.S. Pat. No. 5,833,626) and a device for positioning and fixing of therapeutic, surgical, or diagnostic instruments (U.S. Pat. No. 5,776,144) have been proposed for the pre-operative demonstration of implantable hearing systems and for the psychoacoustical measurement of the auditory threshold in quiet by direct mechanical stimulation of the umbo. Hofmann et al. (German Patent No. 198 21 602) propose a vibration measuring head for evaluation of the movability of the middle ear. The basic embodiment includes a transducer, particularly an electromagnetic transducer, which exclusively is operated in resonance, wherein the movability of vibratorily movable elements of the middle ear structure coupled to the actoric side of the transducer can be evaluated by means of a second measuring coil, because the dampening of the system by the middle ear structure coupled thereto is represented by a variation of the voltage generated by this coil.
In the meantime, the device suggested in U.S. Pat. Nos. 5,776,144 and 5,833,626 was used for clinical examination of test persons having normal hearing. The examination showed in a statistically significant manner that this method is well reproducible and valid, and can be applied without any risk for the safety of the test persons.
However, basically there is the problem, that when using the device and the method for patients with impaired hearing, there is an individually varying audition. The differences particularly reside in spectrally very different courses of the auditory threshold in quiet as well as possibly in a positive recruitment (increase of the steepness of the soundness perception) and a reduced frequency resolution power for above-threshold signals. The known devices and methods scarcely permit successes because an individual compensation of the respective hearing disorder, i.e. an adaptation of the electronic audio signal processing unit driving the electromechanical transducer in the sense of an adaptation of a hearing aid, can not be carried out. This necessarily results in the serious disadvantage of the proposed devices and methods that the pre-operative demonstration never provides the patient with the hearing impression he will encounter later on after implantation and individual adaptation of the implanted hearing system to his individual hearing impairment.
The primary object of the present invention is to devise a device and a method for pre-operatively demonstrating at least partially implantable hearing systems, which permit a non-invasive testing of the hearing capacity as it will be encountered after implantation and adaptation of an individual hearing system.
In accordance with one aspect of the invention this object is achieved by a demonstration device for pre-operatively demonstrating an at least partially implantable hearing system for the rehabilitation of hearing disorders, said hearing system including an electronic audio signal processing unit, said device comprising:
an electromechanical transducer adapted for being non-invasively coupled from the side of the external auditory canal to at least approximately the center of the tympanic membrane and thus to the end point of the manubrium mallei for producing mechanical vibrations of the tympanic membrane,
an electronic audio signal generator unit, and
an electronic audio signal processing unit connected between the audio signal generator unit and the electromechanical transducer for driving the electromechanical transducer, wherein the audio signal processing unit of the demonstration device corresponds to or simulates the electronic audio signal processing unit of the hearing system intended to be implanted.
By the demonstration device of the present invention the action and the sound impression to be expected upon implantation of the respective hearing system can be demonstrated in a very realistic manner to the patient having a hearing disorder.
Preferably, means are provided for adapting the audio signal processing unit of the demonstration device to the individual hearing disorder of the respective patient.
Furthermore, means for playing back a data carrier or a sound carrier are preferably associated to the audio signal generator unit. In this connection all types of signals may be utilized which usually are used for audiological purposes, such as pure sinusoidal sounds, narrow-band noise, wide-band noise, speech, music and so on. Also all known embodiments of data carriers and means for generating these test signals may be used, such as an analog and/or digital generation or synthesizing, an analog or digital storage in all known types of non-rewritable or rewritable analog and/or digital storage media, such as semiconductor storages, analog sound carriers (e.g. magnetic tape), audio CDs, CD-ROMs and so on.
In conformity with the invention means for storing a plurality of parameter sets for setting the audio signal processing unit of the demonstration device, and means for selecting and transmitting to the audio signal processing unit of the demonstration device any one of said plurality of parameter sets may be provided. In such an embodiment of the demonstration device of the invention different xe2x80x9cstandardxe2x80x9d parameter sets for setting the audio signal processing unit of the demonstration device, in which sets the individual parameters are adapted to each other in an advantageous manner, may be determined and stored in advance. The operator of the demonstration device then can select any one or any combination of the stored parameter sets without an individual setting of individual parameters being required. Furthermore, no deepened knowledge of the effects of individual parameters or of the interaction of pluralities of parameters is necessary in order to attain more or less optimum parameter settings, so that the demonstration device then also can be properly operated by less trained personal.
The audio signal processing unit of the demonstration device preferably comprises a programmable processor unit, particularly a personal computer (PC) or a digital signal processor (DSP). The presently used term xe2x80x9cpersonal computerxe2x80x9d or xe2x80x9cPCxe2x80x9d is to be understood as also including notebooks, laptops and the like, as well as any other xe2x80x9cexternalxe2x80x9d computers, i.e. computers which are independent of the transducer driver.
The programmable processor unit may be configured for carrying out the functions of audio signal generator unit as well as of the audio signal processing unit of the demonstration device.
In conformity with a particularly preferred embodiment of the invention the audio signal processing unit of the demonstration device comprises electronic driver means for driving the electromechanical transducer, wherein a digital-to-analog converter may be connected between the programmable processor unit and the electronic driver means. Particularly, when using as the programmable processor unit a personal computer which carries out the functions of the audio signal generator unit as well as of the audio signal processing unit of the demonstration device, the electronic driver means and the digital-to-analog converter may be integrated in a hardware interface which is connected between the personal computer and the transducer.
When, however, the programmable processor unit is a digital signal processor (DSP), a particularly compact demonstration device may be obtained by integrating the electronic driver means, the digital-to-analog converter and the digital signal processor in a hardware interface. In order to simplify the operation of this hardware interface, furthermore display means may be provided for displaying audio signal generation data and audio signal processing data. The display means likewise may be integrated in the hardware interface or may be connected to the latter.
The audio signal processing unit of the demonstration device preferably comprises electronic audio signal processing means and electronic driver means for driving the electromechanical transducer, which are at least approximately the same as electronic audio signal processing means and electronic driver means included in the hearing system intended to be implanted, and which may be integrated in an interface.
In order to attain an impression of the output-side deflection of the transducer which is independent from individual variations of the biological load impedance, the electromechanical transducer preferably has a mechanical source impedance which, in the entire spectral transmission range of the device, is distinctively higher than the mechanical load impedance defined by the biological system comprising tympanic membrane, ossicular chain and inner ear.
The examination may be carried out in a manner which is particularly comfortable to the patient, when the electromechanical transducer comprises a transducer housing which provides for an acoustical encasing that minimizes sound signals emitted by vibrating structures of the transducer to such an extent that an acoustical deafening of the contralateral, non-examined ear becomes unnecessary.
The electromechanical transducer may be based on the electrodynamic, electromagnetic, magnetostrictive, capacitive or piezoelectric transducer principle. Particularly preferred is a piezoelectric transducer because magnetic stray fields may be completely avoided thereby.
In conformity with a further embodiment of the invention, a coupling element may be provided which is adapted to be coupled to the electromechanical transducer and to be non-invasively contacted, through the external auditory canal, with at least approximately the center of the tympanic membrane and thus the end point of the manubrium mallei. Preferably, this coupling element is a rod-shaped member which is stiff in axial direction thereof and which has an actuator end remote from the transducer, which actuator end is configured for a non-traumatic mechanical contact with the center of the tympanic membrane. Advantageously, the rod-shaped coupling element is configured such that it can be easily manually flexed to adapt it to the individual geometrical configuration of the external auditory canal.
Preferably, the electromechanical transducer is disposed within a transducer housing configured for introduction into an inlet zone of the external auditory canal, wherein the transducer housing has geometrical dimensions which are selected such that an examining person, even when using a microscope, has an unobstructed view of the actuator end of the coupling element contacting the center of the tympanic membrane. This permits the examining person to easily introduce the device, while at the same time providing for the safety of the patient.
Furthermore, by connecting the coupling element to the transducer via mechanical plug-type connection means, rather than by a mechanically fixed connection, different coupling elements may be used, which elements may be easily exchanged e.g. for hygienic reasons and which may be configured as disposable articles.
Preferably, the electromechanical transducer, possibly in combination with the mechanical coupling element, has a first mechanical resonance frequency at the upper end of the spectral transmission range of xe2x89xa710 kHz. A broadband behavior and thus short transient times may be attained thereby.
In conformity with a further embodiment of the invention, positioning means are provided for positioning the electromechanical transducer with respect to the umbo. Thereby the transducer, or, when the latter is coupled to the coupling site by a mechanical coupling element, such as a coupling rod connected to the electromechanical transducer, the actor end of the coupling element may be precisely moved to the target point.
Fixing means are preferably provided to obtain a secure, play-free linkage of the positioning means to a human skull and thus to fix the relative spatial positions of the positioned transducer or the coupling element, respectively.
In conformity with a further preferred embodiment of the invention, an intermediate element is provided between the positioning means and the electromechanical transducer, wherein this intermediate element is configured and dimensioned to transmit quasi-steady-state positioning adjustments from the positioning means to the electromechanical transducer, but to sufficiently reduce the transmission of at least dynamic forces from the positioning means to the coupling element to such an extent that the risk of middle or inner ear damage is substantially reduced.
In the demonstration device of the invention, the transducer together with the coupling element, follows the relatively slow position changes which are called quasisteady-state here and which are caused by the actuation of the positioning means. The physician can thus guide the active end of the coupling element precisely and free of relative movements to structures in the human body, especially to the umbo, as the target point. However, in the case of an unintentional external action which generally takes place by jerks and jolts, for example by hitting the positioning means with the hand, an instrument or the like, the dynamic forces acting on the positioning means are kept away from the transducer and the coupling element at least to a substantial extent.
The intermediate element may be made as a spring member, which is a structurally simple approach. The spring member, the electromechanical transducer and the coupling element from a spring/mass system which preferably has a natural frequency in the range from 0.5 to 5 Hz.
A further aspect of the invention is a process for pre-operatively demonstrating an at least partially implantable hearing system intended to be implanted, said hearing system comprising a first audio signal processing unit having a predetermined audio signal processing behavior, and a first electromechanical transducer which is driven by said first audio signal processing unit and which is adapted for being coupled to a pre-selected coupling site for causing mechanical vibrations of the coupling site, said process comprising the steps of:
(a) providing a second audio signal processing unit having an audio signal processing behavior which at least approximates the audio signal processing behavior of said first audio signal processing unit, and supplying test and demonstration signals to the second audio signal processing unit to produce output signals for driving a second electromechanical transducer;
(b) storing the output signals produced in step (a) in a signal storage;
(c) repeating steps (a) and (b) with different sets of audiological adaptation parameters;
(d) non-invasively coupling the second electromechanical transducer from the side of the external auditory canal to at least approximately the center of the tympanic membrane and thus to the end point of the manubrium mallei; and
(e) applying to the second electromechanical transducer output signals stored in the signal storage for causing mechanical vibrations of the tympanic membrane.
Accordingly, the process of the invention is carried out in two phases. In a first phase output signals of the type produced by an audio signal processing unit of the hearing system intended to be implanted are stored in a signal storage for different sets of audiological adaptation parameters. In a second phase, the actual demonstration phase, a transducer (the second electromechanical transducer) is non-invasively coupled from the outside via the external auditory canal to at least approximately the center of the tympanic membrane of the hearing-impaired patient to whom the hearing impression of the hearing system to be implanted is to be demonstrated, whereupon output signals stored in the signal storage are applied to the second transducer to mechanically vibrate the tympanic membrane. Thereby the functions of the implant can be demonstrated to a possible implant carrier in a non-invasive but nevertheless realistic manner.
Different settings of the implant may be simulated and demonstrated, respectively, by applying to the second transducer output signals obtained for different sets of audiological adaptation parameters.
The second electromechanical transducer may be coupled to at least approximately the center of the tympanic membrane directly or via a coupling element which is introduced through the external auditory canal for contacting the tympanic membrane.
These and further objects, features and advantages of the present invention will become apparent from the following description when taken in connection with the accompanying drawings which, for purposes of illustration only, show several embodiments in accordance with the present invention.